Model 493-08 Polyflex Endocardial Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863781 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Model 493-08 Polyflex Endocardial Lead used for in clinical practice?

  The Model 493-08 Polyflex Endocardial Lead is designed to deliver electrical impulses from a pacemaker to the heart’s chambers, helping regulate abnormal heart rhythms (arrhythmias) by ensuring proper conduction. It is specifically intended for use in permanent cardiac pacing systems to maintain reliable and durable pacing functionality within the cardiac environment.

• Is the Model 493-08 Polyflex Endocardial Lead meant for single-use or reusable implantation?

  This device is supplied sterile and explicitly intended for single-use implantation only. It is not designed for reuse, and adherence to sterile medical device protocols is required during handling and storage to maintain its integrity.

• How should the Model 493-08 Polyflex Endocardial Lead be stored to preserve its sterility?

  Since the lead is sterile for single-use, it must be stored according to standard sterile medical device protocols. This typically includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until immediate use. Always follow manufacturer guidelines for storage duration and conditions.

• What regulatory pathway was followed for FDA clearance of this device?

  The Model 493-08 Polyflex Endocardial Lead received FDA 510(k) clearance (K863781) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a predicate device. The decision was made by the Cardiovascular (CV) Advisory Committee and classified as a Class III medical device under regulation 870.3680, reflecting its role in permanent cardiac pacing.